Implant and method for manufacturing same

Abstract

The present invention proposes a method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body such that the body has metallic material. To control the degradation in a desired time window, e.g., between four weeks and six months, the following production method is performed: a) preparing the body of the implant, and b) plasma-chemical treatment of at least a portion of the surface of the body in an aqueous solution by applying a plasma-generating electric alternating voltage to the body ( 5 ) of the implant, said voltage having a frequency of at least approximately 1 kHz, to create a first layer. The invention also relates to an implant obtainable by such a method.

1. A method for manufacturing an implant, comprising an endoprosthesis, having a body comprising a metallic material, the method comprising the following steps:
 a) preparing the body of the implant, 
 b) plasma-chemical treatment of at least a portion of a surface of the body in an aqueous solution by applying a plasma-generating alternating voltage to the body of the implant, the voltage having a frequency of at least approximately 1 kHz, for creating a porous layer on the portion of the surface of the body that is to be treated, and 
 c) performing an aftertreatment to seal the base of the pores without sealing the entirety of the pores to preserve an exposed roughened surface. 
 
     
     
       2. The method according to  claim 1 , wherein the body comprises at least one metallic material that is biodegradable. 
     
     
       3. The method according to  claim 2 , wherein the aqueous solution contains one or more Sr 2− ions, optionally at a concentration of 0.05 mol/L to 2.0 mol/L Sr 2− . 
     
     
       4. The method according to  claim 1 , further comprising before the step of plasma chemical treatment, applying a layer containing at least one element selected from the group consisting of tantalum, niobium, zinc, iron and aluminum to at least a portion of the surface of the body by means of an ionic fluid, by sputtering, high-rate atomization and/or vaporization. 
     
     
       5. The method according to  claim 1 , wherein the porous layer is rinsed in a solvent, optionally with distilled H 2 O and then is dried in a circulating oven at a temperature of at least 80° C. 
     
     
       6. The method according to  claim 1 , wherein the aqueous solution comprises one or more ions selected from the group consisting of phosphates, carbonates and silicates. 
     
     
       7. The method according to  claim 1 , wherein the aqueous solution comprises at least one member selected from the group consisting of a buffer, potassium dihydrogen phosphate and sodium dihydrogen phosphate. 
     
     
       8. The method according to  claim 1 , wherein the surface of the body is treated electrochemically before the plasma-chemical treatment. 
     
     
       9. The method according to  claim 1 , wherein the plasma-chemical treatment of the surface of the body is performed by applying a pulsed voltage to the body, its amplitude exceeding at least approximately 90 V for most of the treatment period and the current density in the plasma-chemical treatment is at least 8 mA/cm 2 . 
     
     
       10. The method according to  claim 1 , further comprising applying a polymer layer to the body of the implant after performing the aftertreatment, wherein the polymer optionally comprises parylene. 
     
     
       11. The method according to  claim 1 , wherein the step of performing the aftertreatment comprises treating the body in a strong base. 
     
     
       12. The method according to  claim 1 , further comprising applying a radiopaque layer to the body of the implant. 
     
     
       13. The method according to  claim 1 , wherein the endoprosthesis is a stent. 
     
     
       14. A method for manufacturing an implant, comprising an endoprosthesis having a body comprising a metallic material, the method comprising the following steps:
 a) preparing the body of the implant, 
 b) applying a layer containing at least one element selected from the group consisting of tantalum, niobium, zinc, iron and aluminum to at least a portion of a surface of the body by means of an ionic fluid containing pyrrolidinium ions, and 
 c) plasma-chemical treatment of at least a portion of a surface of the body in an aqueous solution by applying a plasma-generating alternating voltage to the body of the implant, the voltage having a frequency of at least approximately 1 kHz, for creating a porous layer on the portion of the surface of the body that is to be treated. 
 
     
     
       15. The method according to  claim 14 , wherein the aqueous solution comprises one or more ions selected from the group consisting of phosphates, carbonates and silicates. 
     
     
       16. The method of  claim 14 , further comprising applying a polymer layer to the body of the implant after the plasma-chemical treatment, wherein the polymer optionally comprises parylene. 
     
     
       17. The method according to  claim 14 , wherein the endoprosthesis is a stent. 
     
     
       18. A method for manufacturing an implant, comprising an endoprosthesis, having a body comprising a metallic material, the method comprising the following steps:
 a) preparing the body of the implant, 
 b) plasma-chemical treatment of at least a portion of a surface of the body in an aqueous solution by applying a plasma-generation alternating voltage to the body of the implant, the voltage having a frequency of at least approximately 1 kHz, for creating a porous layer on the portion of the surface of the body that is to be treated, and 
 c) performing an aftertreatment of the body of the implant in an aqueous, strongly basic sodium hydroxide solution and with the action of ultrasound and/or injection of argon and/or nitrogen to create a sealing layer. 
 
     
     
       19. The method according to  claim 18 , further comprising applying a radiopaque layer to the body of the implant. 
     
     
       20. The method according to  claim 18 , further comprising applying a polymer layer to the body of the implant after performing the aftertreatment, wherein the polymer layer optionally comprises parylene.